Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2012
End Date:May 2014

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A Randomized, Double-Blind Study of the Efficacy and Safety of Alirocumab Added on to Atorvastatin Versus Ezetimibe Added on to Atorvastatin Versus Atorvastatin Dose Increase Versus Switch to Rosuvastatin in Patients Who Are Not Controlled on Atorvastatin

This is a randomized, double-blind, active-comparator, parallel-group study in patients at
high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial
hypercholesterolemia (heFH).


Inclusion Criteria:

1. Patients with screening (visit 1) LDL-C greater than or equal to 70 mg/dL with
documented CVD, not adequately controlled with a daily dose of atorvastatin. OR

2. Patients with screening (visit 1) LDL-C greater than or equal to 100 mg/dL at high
risk for CVD who are not adequately controlled with a daily dose of atorvastatin.

Exclusion Criteria:

1. LDL-C greater than 250 mg/dL

2. LDL-C less than 70 mg/dL at the screening visit in patients with history of
documented CVD

3. LDL-C less than 100 mg/dL at the screening visit in patients without history of
documented CHD or non-CHD CVD, but with other risk factors

4. TG greater than 400 mg/dL

5. Homozygous FH (clinically or previous genotyping)

6. Currently taking a statin that is not atorvastatin

7. Currently taking Ezetimibe (EZE)

8. Not on a stable dose of allowable lipid modifying treatments (LMT)

(The inclusion/ exclusion criteria provided above is not intended to contain all
considerations relevant to a patient's potential participation in this clinical trial).
We found this trial at
57
sites
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Overland Park, KS
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Anaheim, CA
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Atlantis, FL
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Auburn, ME
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Bethesda, MD
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Beverly Hills, California 90211
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Beverly Hills, CA
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Boca Raton, FL
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Boise, ID
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577
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Bountiful, UT
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873
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Butte, MT
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356
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Chandler, AZ
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Chicago, IL
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Clearwater, FL
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2032
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Cleveland, OH
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1057
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Dallas (2 locations), TX
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1511
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Edina, MN
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1194
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Fort Worth, TX
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2029
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Greer, SC
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7197
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Herston QLD,
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1357
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Houston, TX
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1793
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Indianapolis, IN
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2127
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Jacksonville, FL
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1994
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Kingsport, TN
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10
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Lakeland, CA
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208
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Las Vegas, NV
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1881
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Lexington, KY
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1813
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Louisville, KY
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586
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Marion, UT
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664
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Meridian, ID
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2197
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Miami (2 locations), FL
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2480
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Milford, CT
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1757
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Mobile, AL
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1624
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Morton, IL
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Newport Beach, California 92660
31
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Newport Beach, CA
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1183
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Newton, KS
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25
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Northridge, CA
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1164
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Oklahoma City, OK
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Olive Branch, Mississippi 38654
1599
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Olive Branch, MS
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2191
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Oviedo, FL
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2125
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Pinellas Park, FL
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Port Gibson, MS
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Port Orange, FL
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943
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Renton, WA
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1524
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Rochester, MN
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364
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Sacramento, CA
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570
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Salt Lake City, UT
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2148
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Sarasota, FL
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1572
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St. Louis, MO
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Summerville, South Carolina 29485
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Summerville, SC
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2136
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Tampa, FL
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427
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Tucson, AZ
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347
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Walnut Creek, CA
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Warwick, RI
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West Palm Beach, FL
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1182
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Wichita, KS
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2188
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Williamsville, NY
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2126
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Winston-Salem, NC
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